Business
Second Traumakine manufacturing site established
Second Traumakine manufacturing site established.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 8543D Faron Pharmaceuticals Oy 05 February 2018 \n\nFaron Pharmaceuticals Ltd\n(\"Faron\" or the \"Company\")\n \nFaron establishes second Traumakine® manufacturing site\n \n \nTURKU - FINLAND, 05 February 2018 - Faron Pharmaceuticals Ltd (\"Faron\") (AIM: FARN), the clinical stage biopharmaceutical company, announces that it has signed an agreement with a second contract manufacturing organization, Lyocontract GmbH, for additional commercial scale manufacturing of Faron's wholly owned product Traumakine (drug product FP-1201-lyo), for the treatment of Acute Respiratory Distress Syndrome (ARDS). \n \nLyocontract, based in Ilsenburg, Germany, will provide a second independent manufacturing facility for Traumakine, to complement the primary site currently operated by Rentschler Biopharma SE under a separate manufacturing and supply agreement. These two manufacturing sites will support Faron's commercial preparations for Traumakine in the event of positive results from the pivotal pan-European INTEREST trial in patients with moderate and severe ARDS. Data from this trial continue to be expected during the first half of 2018.\n \nA single production batch at Lyocontract will contain 120,000 vials of FP-1201-lyo equalling approximately 20,000 Traumakine treatments. Faron anticipates that it will have approximately 100,000 available treatments for distribution in global markets by mid 2019, assuming that Traumakine is granted the necessary regulatory approvals. \n \nARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%1,2,3, for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma. Faron estimates there are around 300,000 plus annual cases in Europe and US alone. Faron completed the recruitment of 300 patients with moderate and severe ARDS for the pan-European pivotal trial INTEREST in December 2017. \n \nDr Markku Jalkanen, CEO of Faron, said: \"We are very pleased to secure additional manufacturing for Traumakine drug product FP-1201-lyo as we continue to prepare for commercialization. This will enable us to provide Traumakine supply for early acc...